All medical devices marketed in Europe need to have a mandatory CE certification, which guarantees that the device meets relevant regulatory requirements for proper and safe use.

Following withdrawal of the CE mark for Aquilon’s nebulizers, the company “has continued to place the nebulizers on the market,” according to an MHRA press release.

This means that although the affected nebulizers and packaging still exhibit the CE mark from before it was withdrawn, it was not obtained through appropriate regulatory oversight.

“We have been made aware that the manufacturer has continued to sell nebulizers even after their CE certification was withdrawn. We cannot guarantee they have been manufactured to an appropriate standard,” said John Wilkinson, director of medical devices at MHRA.

Because the safety of the devices cannot be assured, MHRA issued a Medical Device Alert to caution patients and all relevant healthcare professionals — medical, nursing, and technical staff — against using these specific nebulizers. The MHRA advises the use of alternative products when available.

MHRA established April 5 as the deadline for healthcare professionals to implement the required measures.

“We are taking action, as a matter of priority, to make sure people are aware the CE mark has been withdrawn and that these devices should not be used and should be disposed of,” Wilkinson added. “These devices deliver potential life-saving treatment and it is vital they operate correctly when needed.”

According to MHRA, more than 8,000 Aquilon nebulizers are affected. The alert concerns Aquilon2, Aquilon, Aquilon+, and Aquilon Pro series manufactured since April 1, 2015.

U.K. patients should immediately follow the advice of the MHRA if they suspect a nebulizer is affected.

The regulatory agency also says that patients should speak with their healthcare professional or general practitioner to receive help to find out if their device is affected, and to get information on how to dispose of it and get a replacement.

“Patient safety is our highest priority and we urge anyone with questions to speak to a healthcare professional as soon as possible,” Wilkinson said.

Disclaimer:

Cystic Fibrosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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